At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years with histopathologically documented diagnosis of malignant GIST that is unresectable and/or metastatic
- ✓Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample
- ✓At least one measurable lesion not previously embolized or irradiated
- ✓Life expectancy ≥6 months and adequate end organ function
- ✕Patients with fewer than five years of disease-free survival from any other (non-GIST) malignancy except basal cell skin cancer or cervical carcinoma in situ
- ✕Known brain metastases
- ✕Grade III/IV cardiac failure (NYHA criteria), severe concomitant disease, acute or chronic liver disease (chronic active hepatitis, cirrhosis), or HIV infection
- ✕Chemotherapy or investigational therapy within 4 weeks (6 weeks for nitrosourea/mitomycin-C) prior to study entry; radiotherapy to ≥25% of bone marrow
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open, Randomized, Phase II Study of Glivec in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Plus 10 Year Extension Study
In Brief
A Phase 2 clinical trial evaluating Imatinib mesylate for Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST). Completed, enrolled 148 participants across 5 sites in 3 countries.
Detailed Summary
In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.
Study Details
Timeline
Interventions
Participants were randomized 1:1 to receive imatinib mesylate 400 mg/day or 600 mg/day. Upon unsatisfactory treatment effect on the starting dose of 400 mg/day or 600 mg/day imatinib mesylate, in the opinion of the treating physician, a dose increase up to 600 mg/day or 800 mg/day, was allowed provided that the participant continued to benefit from the treatment and in the absence of safety concerns.